Date: Thu, 08 Feb 1996 19:40:56 -0800 (PST)
From: "John S. James"
Subject: AIDS Treatment News #240
AIDS TREATMENT NEWS Issue #240, February 9, 1996
phone 800/TREAT-1-2, or 415/255-0588
CONTENTS:
Protease Inhibitors at Retroviruses Conference
Protease Inhibitors in Human Testing: Annotated List
Ritonavir (Abbott Protease Inhibitor) Proves Survival Benefit
in Late-Stage AIDS
Agouron Starts Phase III Protease Inhibitor Studies
Vancouver International Conference: Community Booths Deadline
Extended
FDA Antiviral Advisory Committee Meetings This Month
Prisoners: Send Address Updates; Contacting Organizations
NMAC Skills Building Conference in South Africa: Facilitators
Wanted
Computer Censorship Law, ACLU Test Case, Begin February 8
***** Protease Inhibitors at Retroviruses Conference
The big media story from the 3rd Conference on Retroviruses
and Opportunistic Infections concerned two protease
inhibitors, one developed by Abbott Laboratories, the other
by Merck & Co. Triple combination trials, which combined each
of these experimental drugs with two approved AIDS drugs,
showed exceptionally promising results.
The overall outcome was not a surprise, as the general
picture has been discussed quietly among inside-track
researchers, physicians, and activists for several weeks. But
the data had not been available before.
The ritonavir article below will look at the details of the
new Abbott trial results, and at other research on this drug
presented at the conference. Next week we will look at the
Merck protease inhibitor, and at other news from the
conference, which was an important meeting even aside from
the high-profile protease inhibitor reports.
For More Information
Jules Levin of the National AIDS Treatment Advocacy Project
(NATAP) has written in-depth articles on the protease
inhibitor news from the 3rd Conference on Retroviruses and
Opportunistic Infections. They are on the NATAP Web site,
http://health.nyam.org:8000/public_html/natap (note that "l"
is always the letter in this address, not the number one).
Also, audio tapes of many of the sessions of the 3rd
Conference on Retroviruses and Opportunistic Infections are
available from Sound Images, Inc. 7388 South Revere Parkway,
Suite 806, Englewood, Colorado, 303/649-1811, fax 303/790-
4230. Probably the most important single set of tapes is for
Late Breaker Session #1, which includes the major Abbott and
Merck reports.
***** Protease Inhibitors in Human Testing: Annotated List
This brief directory of some protease inhibitors includes
company, generic name, brand name if known (in parentheses),
and comments. It is included to help readers follow our
coverage of these drugs.
* Merck & Co.: indinavir (Crixivan(R)). This drug appears to
be generally the best regarded among treatment activists at
this time. It has very good viral suppression, and apparently
limited side effects. The main disadvantage is that viral
resistance and cross resistance can develop rapidly,
especially if the drug is used improperly. It is possible
that indinavir might still provide some benefit against
resistant viruses.
* Abbott Laboratories: ritonavir. The main advantage of
ritonavir is that now it has proven survival benefit in
advanced AIDS; the other protease inhibitors have not yet
been tested in any trial that could have determined whether
or not they also can keep people alive longer. Ritonavir's
main disadvantage is serious interactions with a number of
other drugs. Also there are often gastrointestinal side
effects, at least with the current formulation.
* Hoffmann La-Roche: saquinavir (Invirase(TM)). This is the
only protease inhibitor which is FDA-approved at this time.
It seems to have less viral resistance problem than the Merck
and Abbott drugs. Its main disadvantage is that it was
approved at a dose which is clearly too low; drawbacks to
just taking more include the drug's great expense, and the
lack of much safety data at higher doses. The dosage problem
is being corrected, with a new formulation which will deliver
a higher dose economically; however, it will take some time
to get enough clinical-trial experience with the new dose and
formulation for the FDA to be confident of safety, and
approve this formulation for marketing.
* Agouron Pharmaceuticals, Inc.: nelfinavir mesylate
(VIRACEPT(TM)). See the clinical trials announcement, below.
* Glaxo Wellcome/Vertex: 141W94, or VX478. No information
about this protease inhibitor was presented at the
Retroviruses conference, except for a passing reference in
one abstract.
* CIBA-Geigy Ltd.: CGP 61755. This drug is in early
development, and is not yet available in trials in the U.S.
There was one abstract at the conference.
* Pharmacia & Upjohn: This company's protease inhibitor has
not yet been tested in people; the first small, single-dose
human studies might start later this year. There was no
information about this drug at the conference.
***** Ritonavir (Abbott Protease Inhibitor) Proves Survival
Benefit in Late-Stage AIDS
by John S. James
The most important single presentation at the Retroviruses
conference was the report from Abbott Laboratories that its
protease inhibitor, ritonavir, reduced the risk of death by
43% in a clinical trial with 1090 volunteers. This is the
first time that a protease inhibitor has been proven to
extend life. Abbott ran this study remarkably quickly; the
volunteers were recruited between April and July 1995, and
yet the researchers were able to report survival results in
late January.
All the volunteers had a CD4 (T-helper) count of 100 or less;
the median CD4 count was about 30, and about a quarter of the
volunteers had counts under 10. All had used approved
antiretrovirals (mostly AZT and d4T) for more than nine
months. These volunteers were randomly assigned to receive
either ritonavir (600 mg twice daily) or placebo for one
year. But after four months, anyone who developed an AIDS-
defining event was allowed to end the placebo phase of the
study and use the drug.
In addition to the study drug, the volunteers were permitted
but not required to continue using up to two other anti-HIV
drugs; if they chose to do so, they needed to be on these
drugs for at least six weeks before entering the study. 3TC
was not permitted, since it was not officially approved when
this trial started, although it was widely available in an
expanded-access program. Also, volunteers were not allowed to
use any other protease inhibitor.
The double-blind portion of this one-year study was stopped
early because it reached a predetermined stopping number of
191 clinical outcomes. The 43% reduction in risk of death was
found after the volunteers had been in the study for a median
of 6.1 months. (The improvement was even more impressive
after the first month of the study, with a reduction in the
risk of either an AIDS-defining event or death of 58%. The
risk reduction was somewhat less for CMV retinitis than for
other AIDS-defining conditions.) Both the six-month survival
result, and the one-month progression-or-survival result,
were statistically significant. On the other hand, 17% of the
volunteers on ritonavir had to discontinue treatment due to
adverse events, as compared to a 6% discontinuation rate on
the placebo.
Viral load, CD4, and CD8 measures were studied in a subset of
the volunteers in this trial, and were reported in a separate
paper, reviewed below.
Ritonavir is the only protease inhibitor so far to have
proven survival benefit. It is widely suspected that other
protease inhibitors would have comparable results if they
were tested the same way. But in view of Abbott's result, as
well as new information about viral load, there would be
ethical problems in running the same placebo trial with other
drugs.
Comment
In all past trials it has been very difficult to prove a
survival benefit from a drug. (The earliest controlled study
of AZT did show a survival benefit of AZT vs. placebo, but
that result is not entirely credible because of problems with
the trial.) How could Abbott prove survival benefit today in
such a short time?
There are basically two reasons. First, the new protease
inhibitors, especially in combination with other
antiretrovirals, are much more effective against HIV than
previous treatments were, making it easier to show a
difference between treated and untreated patients.
Also, Abbott overcame the widespread industry prejudice
against allowing volunteers with very low CD4 counts in
trials. Many researchers had come to believe that these
patients were too advanced to benefit from antiviral drugs;
companies excluded them so that their drugs would look good.
But the belief that these people could not benefit came from
experience with much less effective drugs. In addition, for
several years it has been known that when persons with AIDS
are receiving excellent medical care, almost all the deaths
occur in those with a CD4 count below 50. Abbott realized
that the very people who were being excluded by other
companies were the ones it needed to prove that its drug
could prolong life.
Recruiting patients is often the critical weakness of
clinical trials. The ritonavir trial recruited quickly
because persons with a low CD4 count had no other trials
available, because Abbott opened 67 trial sites in the U.S.,
Europe, and Australia, and because persons in the trial could
continue the anti-HIV medications they were already using.
This trial has been well accepted by patients and activists.
Ritonavir does have a major disadvantage, however. It
interacts with many other drugs by preventing them from being
metabolized by the body, causing the normal dose of some
drugs to become a dangerous overdose. Some medications can be
used with appropriate dose adjustments; others cannot be
combined with ritonavir at all.
The Merck protease inhibitor indinavir (Crixivan(R)) has much
less of a drug-interaction problem, and probably at least as
much ability to suppress HIV as ritonavir does. But it does
not have data proving that it prolongs survival.
Where do we go from here in proving clinical benefit? Must
every new protease inhibitor prove that it can extend life?
We think not, for several reasons:
* Any proof of survival benefit requires that people die in
the trial. These trials become increasingly problematic
ethically, as evidence accumulates that viral load changes
predict clinical response to therapy.
* It is clearly unworkable to prove survival benefit EARLY in
HIV infection, because the trial would have to run for many
years before deaths occurred. It would be nearly impossible
to run such a trial, and unconscionable to deny early
treatment until its results were in. We will have to find
other ways of investigating the effects of early treatment,
based on better understanding of the disease process.
* All indications to date are that the key contribution of
ritonavir was in lowering viral load. If the viral load could
be lowered as much by another protease inhibitor, by other
drugs, or even by herbal treatment, without introducing major
toxicities, all indications are that the survival benefit
would be about equal.
* Viral load trials can be run much more rapidly than
clinical-endpoint trials, with far less resources, allowing
screening of many drugs and combinations at all stages of HIV
disease, and without ethical problems as no one has to die or
suffer significant harm.
We believe that clinical-endpoint trials should be used very
selectively, and no longer be required by the FDA for every
new drug. Resources should be shifted to rapid trials which
look at viral load, CD4 counts, and other measures of HIV
disease status, to determine how well treatments are working
-- trials which include long-term followup. Resources now
spent on confirming final certainty in regulatory decisions
should be focused instead on answering physicians' practical
questions on how best to use the drugs.
What about the risk of long-term drug toxicity? This is
always a danger; but is the best way to look for it a
randomized trial designed to determine whether or not the
drug works against the disease? If the benefit and harm of
the drug are nearly balanced, then a clinical-endpoint trial
might be necessary to tell which was greater. But today there
are many protease inhibitors and combinations with major
impact on HIV; a drug which caused equivalent damage in side
effects would be abandoned long before such a trial could be
completed.
This issue remains controversial, however, because in theory
at least, clinical benefit trials still offer the most
certain proof that a drug does more good than harm. Many
people are philosophically attached to this promise of
certainty.
[Note: The ritonavir survival results were presented in the
"late breaker" session of the conference, abstract #LB6a. The
late breaker session is for results which are too recent to
have been submitted by the regular deadline, but important
enough to be accepted anyway.]
Other Ritonavir Results
The following additional results on ritonavir were presented
at the Retroviruses conference:
* Ritonavir plus AZT plus ddC produced very good viral load
suppression. A study in France treated 29 patients with
advanced, untreated HIV infection with this combination; 21
of them were able to tolerate the treatment for at least six
months. Median viral load decreased to less than 1% of its
starting value by month two, but was slightly over 1% at
month six. Median CD4 count went from 156 at baseline to 303
at month six. Twelve of the 21 patients had the number of
infectious cells reduced by over 99.99%. [Abstract #285]
* A substudy of the ritonavir survival trial reported viral
load, CD4, CD8 changes in the first 159 patients enrolled who
started with a viral load over 15,000 copies (which included
most patients, since the typical viral load was about 200,000
copies). They were studied for the first four months of the
trial (that is, before the point at which some patients were
allowed to leave the placebo-controlled treatment and begin
open-label ritonavir). The greatest difference in viral load
between the ritonavir and placebo groups was 1.3 logs (20
fold), measured at two weeks; at the end of the four-month
substudy, the viral load of the treatment group was about 0.6
logs (4 fold) lower than that of the placebo group, which had
changed little during the trial, as expected. The greatest
average difference in CD4 count was 45, measured at 16 weeks.
The greatest difference in CD8 count was 363, measured at
eight weeks (over an average baseline value of about 500).
All these differences were highly statistically significant.
[abstract #LB6b, with additional information from the oral
presentation.]
* An Australian paper looked at immunological changes in 21
patients treated with ritonavir, using two-color flow
cytometry, and found improved immunologic function, as well
as increased cell number. [abstract #232]
* A study in animals found that when ritonavir was combined
with other protease inhibitors, the blood level of the other
drug was greatly increased. This effect could vary greatly;
the increase in blood level of saquinavir (the Roche protease
inhibitor) was 29,000 percent (290 times), while the increase
in indinavir (the Merck protease inhibitor) blood level was
800%. [abstract #143]
* A resistance study compared viral load and particular
mutations of HIV in seven patients treated with a low dose of
ritonavir without other drugs. After two weeks, average viral
load had decreased by 1.62 logs (42 fold); but later the
viral load increased, and it returned to baseline values in
six of the seven patients. The rise in viral load was
strongly associated with mutations, especially at positions
82 and 63 of the protease gene. The mutant virus appears to
have been present before the patients ever saw the drug, but
at very low levels, less than one one hundredth of one
percent of the total virus. [abstract #201]
* A retrospective study compared the CD8 count changes in
eight previous trials, of nucleoside analog reverse
transcriptase inhibitors (such as AZT, or 3TC), non-
nucleoside analog reverse transcriptase inhibitors (such as
nevirapine), and the protease inhibitor ritonavir. Patients
using ritonavir had large CD8 increases, up to 892 in higher-
dose groups -- compared to small increases, or even
decreases, with the other therapies. [abstract #451]
***** Agouron Starts Phase III Protease Inhibitor Studies
Agouron Pharmaceuticals, Inc. is starting two large studies
of its protease inhibitor VIRACEPT(TM) (nelfinavir mesylate)
in combination with approved HIV drugs. A smaller study of
nelfinavir alone is also beginning.
One trial, protocol 506, will study two doses of nelfinavir
(500 and 750 mg) combined with stavudine (d4T), vs. stavudine
alone. Volunteers will have a two-thirds chance of getting
one of the combination regimens. This trial will enroll 240
patients; three quarters of the slots are for persons who
have been treated with AZT for at least six months, and the
other 25% are for those who have either had no AZT use, or
less than six months of it. Volunteers must be at least 13
years old, and must have a CD4 count of at least 50 and a
viral load of at least 15,000 copies. They cannot have used
any protease inhibitor, nor d4T, at any time. In case of
treatment failure (defined as return to baseline viral load,
CD4, or both on two consecutive visits following four weeks
of drug administration), certain treatment changes will be
allowed. This study will last 24 weeks, and may provide drug
for an additional six months.
Another trial, protocol 511, will study the same two doses of
nelfinavir in combination with AZT plus 3TC, vs. AZT plus 3TC
alone. Volunteers will have a two-thirds chance of getting a
triple combination treatment. They must be at least 13 years
old, and have a viral load of at least 15,000 copies. They
can have any CD4 count, but cannot have received any anti-HIV
drugs except for a lifetime total of less than one month of
AZT. This study will last for 24 weeks, after which drug may
be provided for another six months. Provisions similar to
protocol 506 are available for treatment failure. This study
is seeking to enroll 210 patients.
Protocol 505 will study the same two doses of nelfinavir
alone, compared to placebo. After four weeks, the placebo
volunteers will be randomized into one of the treatment
groups. Volunteers must have a CD4 count of at least 50, and
a viral load of at least 15,000.
For more information about these trials, which are now
recruiting in about 30 cities in the U.S., call Agouron's
information line, 800/501-2474, and follow the voicemail
instructions to find a contact number in your city.
Comment
It is difficult for patients and physicians to make decisions
about protease inhibitor therapies at this time. The main
disadvantage of the Agouron drug is that much less is known
about it than is known about the Merck, Abbott, or Roche
protease inhibitors. On the other hand, it may not have some
of the drawbacks of those other drugs. For today and for the
near future, there is no way to know which treatment options
are best.
***** Vancouver International Conference: Community Booths
Deadline Extended
The February 1 deadline to apply for an NGO (non-government
organization, i.e. not-for-profit organization) booth at the
XI International Conference on AIDS (Vancouver, July 7-12,
1996) has been extended. There is no charge for these booths,
but a deposit is required, to discourage organizations from
reserving space and not using it.
For more information, call the XI International Conference on
AIDS, Exhibit Management Office, attn: Ms. Val Levy, 1030
Mainland St., Vancouver, V6B 2T4, 604/688-0855, fax 604/688-
0270.
***** FDA Antiviral Advisory Committee Meetings
The Antiviral Drugs Advisory Committee has four AIDS-related
meetings in the next month; all are open to the public, and
public testimony will be taken. Note that some information
about the locations which was published in the FEDERAL
REGISTER on January 31 is erroneous.
February 28, 8:30-5:00: Recent studies with nucleoside
analogs (ACTG 175, the Delta study, and others), and how the
results should affect standard of care.
February 29, 8:30-5:00: Ritonavir (Abbott Laboratories
protease inhibitor).
March 1, 8:30-5:00: Crixivan(R) (Merck & Co. protease
inhibitor).
March 1 also, 8:00-5:00: A joint meeting of the Antiviral
Drugs Advisory Committee and the Endocrine and Metabolic
Drugs Advisory Committee, on Serostim(TM) (human growth
hormone) to treat AIDS-related wasting. (This meeting will be
at the Holiday Inn, Silver Spring, Maryland; the other three
meetings will be at the Holiday Inn, Gaithersburg, Maryland.
The Antiviral Drugs Advisory Committee will be divided for
the two simultaneous March 1 meetings.)
For the most current information, call the FDA Advisory
Committee Hotline, 800/741-8138. When it asks for a 5-digit
code, enter the code for the Antiviral Drugs Advisory
Committee, 12531.
***** Prisoners: Send Address Updates; Contacting
Organizations
If you are transferred or released, send us your new address
if you want to continue receiving AIDS TREATMENT NEWS. We
will automatically continue a free subscription for six
months after you are released; after that time you can use
our regular sliding scale if you have financial difficulties.
But if you do not send us a forwarding address, our mailings
are returned and there is no way we can contact you.
Also, in our January 5 issue (#238) listing of AIDS
organizations, we only had space to publish telephone
numbers, not addresses. If you need to contact one of those
organizations but cannot call them, you can send a letter to
us, and we will forward it to them for you.
***** NMAC Skills Building Conference in South Africa:
Facilitators Wanted
The National Minority AIDS Council, working with several
other organizations, will hold the NMAC Skills Building
Conference for South African Community-Based AIDS Service
Providers, in Johannesburg, April 15-19. NMAC is now seeking
ten facilitators to help with this training conference; two
will receive full travel expenses, the others partial
expenses.
Applications are due February 20. For more information, call
Jackyie Coleman or Harold Phillips at 202/483-6622.
***** Computer Censorship Law, ACLU Test Case, Begin
February 8
by John S. James
On February 1 both houses of Congress passed The
Communications Act of 1995, the major telecommunications bill
which includes the computer censorship provisions described
in previous issues of AIDS TREATMENT NEWS (issues #227, #229,
#236, #237, and #238). The censorship legislation will take
effect when Clinton signs the bill, probably on February 8.
Unless the Supreme Court rules the provision
unconstitutional, it is now a felony punishable by five years
in prison for anyone in the U.S. to just RECEIVE an "obscene"
communication by computer, even in your own home by private
email or otherwise, even if you never show it to anyone -- up
to ten years for the second and each subsequent reception,
with a fine for each offense up to $250,000. You do not need
to know that the communication is legally obscene -- just
knowing it is sexually oriented is enough. By the time you
see it to judge whether it is obscene, the crime has already
been committed. And if you used the Internet, open-and-shut
evidence against you passed through any number of different
sites controlled by different organizations, and can remain
there for years, legally dangerous until the statute of
limitations expires.
Abortion became an issue on the day of the final vote in
Congress, because the same legislation likewise makes it a
felony to knowingly receive by computer (as well as to send)
any information about how an abortion pill or other device
can be obtained or made. Members of Congress disagree as to
whether all of the prohibition of abortion information has
already been ruled unconstitutional. As a compromise, some
sponsors of the censorship legislation read language into the
CONGRESSIONAL RECORD saying that Congress did not intend the
telecommunications bill to criminalize abortion information;
this might help if someone is prosecuted for discussing
abortion by computer. Congress was unwilling to make any
change in the language of the bill, however, because it was
determined to pass the entire telecommunications bill that
day or the next, before it went home for recess. (For more
information on this abortion controversy in the
telecommunications bill, see the SAN JOSE MERCURY NEWS,
February 2, page 1.)
These obscenity and abortion provisions of the law have
nothing to do with the protection of minors, since they apply
to anyone, even if no minor is involved in any way. About the
only fact in your favor is that prosecution would presumably
have to occur in your local area, or wherever you were when
you received the message (not anywhere in the country, as
with other sections of the law); in many areas, such as San
Francisco, malicious or political prosecution of an
inadvertent or incidental offense would seem unlikely. And
the law applies to "interstate commerce," so it might not
apply to local use of a local bulletin board not connected to
the Internet.
Few members of Congress even knew that this provision was in
the legislation until the day of the vote on the entire
telecommunications bill, when the abortion issue was raised
by Congresswoman Pat Schroeder. There have never been
Congressional hearings on any of the computer censorship
legislation; most members of Congress did not follow this
issue at all. And the new crime of receiving information by
computer was created by a few words in a six-page list of
"technical" changes, words which apply an unrelated law
(against importing pornography and abortion devices) to
people who just explore on their own computer. This provision
did not appear in the official text of the telecommunications
bill until the morning of February 1, the day of the final
vote in both houses of Congress. It never appeared anywhere
in Thomas, the Library of Congress Web site intended to
provide the public with the text of legislation Congress is
currently considering, until after final passage. (The
language has existed unofficially since December or early
January, and it has been posted on public Web sites by civil
liberties organizations; but it was not made official, and
therefore not released to the public through usual channels,
until shortly before the final vote in Congress. Those who
looked where one would normally look for pending legislation
did not find it. There appears to have been a deliberate
effort to prevent the public from knowing, by keeping the
censorship language in unofficial, unpublished status, until
the day Congress cast its final votes.)
The better-known provisions of the bill are equally
threatening. Putting any "indecent" message on the Internet
is now a felony punishable by two years in prison and a
$250,000 fine -- even if the same text or picture would be
legal if published in a newspaper. "Indecent" is not clearly
defined -- but redeeming social importance is not a legal
defense (Congress rejected a proposal to exempt such
material). And the indecency legal standard is so broad that
it may even include the Bible; the King James version uses
one of the Federal Communication Commission's "seven dirty
words," a word specifically defined as indecent by the U.S.
Supreme Court (II Kings 18:27).
Also, the crime is committed wherever someone under 18
RECEIVES the material, meaning that a person can be
prosecuted anywhere in the country that prosecutors or
influential organizations may be so inclined.
This new law affects AIDS TREATMENT NEWS, despite our
completely non-sexual material:
* If we set up a Web site or any other computer facility
which allows many-to-many discussion, we may be criminally
liable for messages others post on our site; both the text of
the legislation and the statements of its supporters in
Congress suggest that this is the Congressional intent, as
service providers are specifically exempted for "providing
such access or connection that does not include the creation
of the content of the communication," language apparently
intended to protect companies in the business of leasing
phone lines, computer hardware, etc. In a Web site, we would
of course be creating content. No one knows if removing any
problematic message as soon as we become aware of it would be
enough to avoid trouble.
* If we set up an annotated directory of where to find AIDS
information on the Internet and elsewhere online (which we
have been planning to do), we may similarly be criminally
liable for material that appears in any system we point to or
describe, in the U.S. or abroad -- either material which
exists when we set up the link, or which is added in the
future -- even if we do not let the public add any
information to our own site. What if a site we link to is
inoffensive, but sites it links to are not? (It can take
surprisingly few successive links to reach from a large
directory to almost any site on Earth.) Obviously we cannot
keep monitoring all AIDS-related systems on the Internet,
which are the systems our directory would point to. We may
have to publish our online directory in print only, and not
allow copies online.
* The law against receiving anything obscene makes it
dangerous to explore what information is available. Sexually
explicit sites sometimes include an AIDS section; if we must
never look at those sites, we will not have a comprehensive
picture. In order to obey the law, we may have to travel
abroad, or ask persons abroad to research certain areas for
us.
This concern may seem exaggerated, when no one is likely to
prosecute AIDS TREATMENT NEWS for researching and running an
AIDS directory on the Internet. But the issue is not only the
actual risk of prosecution; also it is how we define
ourselves and set the policies that build our relationships
in society. We are not comfortable if enforcement of the laws
literally as written could send us to prison for decades --
no matter how unlikely this is to actually happen.
* Many academic archives, directories, and other information
services now available on the Internet are likely to
disappear, and many others will silently never begin -- even
concerning completely non-sexual topics. Manual screening of
massive back archives to assure legality would be
prohibitively expensive for most institutions, as would
sophisticated legal advice. And no software could screen the
material and tell what might upset a prosecutor or jury
somewhere, sometime, under who knows what political
atmosphere or regime. Administrators at academic, government,
and other large institutions are cautious by nature, and are
likely to avoid possible trouble by not allowing their
experts to make information available to the public. (The
remarkable tradition of open access on the Internet could be
lost permanently, even if the law is later changed -- because
universities may find that they need to withhold their data
in order to trade it to assure permission for their scholars
to access the databases of others. This dynamic could
permanently restrict to large institutions information which
is now available to all.)
* And of course it will be more difficult to publish our
material on the Internet, because we will need to find
service providers willing to check everything we write in
advance, or who know us well enough to trust us not to get
them in trouble. We will always be able to find servers to
carry us, but we may be blocked from public areas of the big
service providers where most people have their accounts. We
can still distribute our material by email, but it will be
more difficult to reach new people and let them know what
resources exist.
Why not avoid some of the problems by restricting our Web
page to adult-only areas, as supporters of the law have
suggested? One major reason is that there are no adult-only
areas on the Internet of any consequence -- and there never
will be, no matter what technology and institutions are
developed. The reason is that the Internet is what could be
called an information commons -- and inherently there is only
one of those, not one for adults only and another for
everyone. Once you limit or restrict a commons, it is not a
commons any more, but a proprietary system controlled by
somebody, because someone must police the restriction. This
owner, manager, or authority can then police content, too,
imposing whatever political or other restrictions it wishes.
You no longer have a First Amendment right to be heard, just
as you have no First Amendment right to be published in a
particular newspaper. When a commons has been enclosed, its
essence has been destroyed.
Strategy
AIDS organizations had no input at all into the new
censorship legislation. In the past, our strategy at AIDS
TREATMENT NEWS was to inform the AIDS community about the
threat, so that it could have input into what Congress did.
But there was no time, because the censorship provisions
appeared dead until just weeks before they were locked in
concrete, with Congress unwilling to change even a single
word before final passage.
Now that it is too late to prevent the legislation, other
strategies are needed. At this time we see three:
* Support the court challenges which are now being prepared
by the American Civil Liberties Union and others (see below).
Three AIDS service organizations are among the plaintiffs in
this ACLU lawsuit.
Much of the new law is likely to be declared
unconstitutional, as violating the First Amendment of the
Bill of Rights. But court decisions could be many years away.
And no matter what the courts do, we will need to fight this
issue forever; we will need both institutional coalitions and
personal working relationships with civil libertarians.
* Find and publish ways of staying out of trouble. For
example, it still appears safe to distribute completely non-
sexual information (such as AIDS TREATMENT NEWS) by email. We
can now focus our computer distribution efforts on much more
skillful use of email lists, which clearly needs to be done
anyway (NOT using lists to broadcast massively as junk mail,
but targeting massively yet with precision those who are
likely to be interested, approaching dozens or hundreds of
existing online communities, each in its own terms, its own
contexts).
So far we do not know anyone who has learned how to do this
well on the Internet. The AIDS community and others can apply
their full energies to building expertise in appropriately
targeted mass distribution, with confidence that this avenue
will always be open, while the bill's legal consequences for
participatory Internet sites are worked out.
Certainly we will seek legal advice, but no one can know how
the law will be enforced. Our guess is that for some time it
will be enforced selectively -- usually against those
actually involved with pornography, sometimes against
individuals and organizations targeted for their political
work (especially gays), and occasionally against ordinary
people whose incidental transgression happens to come to
someone's attention and fit their agenda. But if a
bureaucracy of inquisition develops, it will need cases to
justify its existence, and the proportion of political and
incidental prosecutions will increase. The fines of up to
$250,000 per message could also motivate prosecutions.
Enforcement philosophy is likely to depend heavily on the
political atmosphere of the time, and on who is President.
* It is becoming clear that without a mass movement to defend
civil liberties in the digital age -- comparable to what the
National Rifle Association has done over the years on behalf
of gun owners, or the pro-choice movement in supporting
abortion rights -- we face increasingly serious threats to
our future. Telephone and video are now merging with
computers; soon all of the important means of public
communication may come under the same censorship which
computer users now face. And computers have unprecedented
ability to preserve all traces of communication forever,
making messages instantly available by person, topic, or any
other search criteria desired; the cost of storage is now so
low that it is becoming feasible to archive everybody's
online communication. (Also, "spy viruses," computer viruses
that instead of being pranks or causing immediate damage,
secretly collect information and ship it to other parties
through telephone or data lines, may either steal business
information or turn one's own computer into an informer.) The
new law imposes prohibitions so broad and undefined that
anyone can be targeted for discriminatory enforcement, for
political, personal, or other reasons, because no one can go
though their whole life using computers regularly without
ever making a mistake. The new law sets the stage for massive
abuses; and the U.S. can use its superpower muscle to require
such abuses elsewhere.
The only long-term protection is well-organized mass
movements to make sure that the First Amendment rights U.S.
citizens have defended throughout this nation's history are
still meaningful, for today and for tomorrow. Congress could
pass the current law only because it heard from very few
people who knew or cared. That must never be allowed to
happen again.
But in civil liberties -- as also in AIDS -- we have never
yet found an organization that offers meaningful
participation to any willing, committed volunteer, regardless
of what skills they have, and wherever they may live. Some
right-wing organizations do seem able to do this. Religious
groups may have an advantage, because they can offer prayer
at first, allowing people to become comfortable with each
other before the egos and divisiveness of politics are
introduced. Building equally massive grassroots organizations
to defend a free society, instead of taking freedom away in
the pursuit of power, is today's critical bridge to moving
forward.
Test Case Filed This Week
As this issue went to press on February 7, the ACLU announced
that it is filing a test case (ACLU v Reno) against the
computer censorship provisions of the telecommunication law,
immediately after Clinton signs the legislation (probably
February 8). The group of 20 plaintiffs in this case includes
three AIDS organizations:
* Critical Path AIDS Project in Philadelphia, which receives
up to 10,000 access requests per day for AIDS information,
reaches some of the most underserved communities in the
nation, and will soon offer AIDS information in eight
different Asian languages;
* AEGIS (AIDS Education Global Information System) in
Southern California, which operates a free computer bulletin
board with one of the largest online archives of AIDS
information in the world; and
* The Safer Sex Page, a large archive of sex education
materials on the World Wide Web which receives 35,000 access
requests per week from around the world.
Other plaintiffs include Human Rights Watch (at risk because
its reports include accounts of rape and torture in
documentation of human-rights violations), Planned Parenthood
Federation of America (which provides information on topics
which include abortion), and the Institute for Global
Communication (which operates a computer facility that serves
about 400 nonprofit groups and 500 schools).
Also note: A number of World Wide Web sites are reversing the
contrast on their lettering to turn their pages black, for a
two-day protest after Clinton signs the bill, which he is
expected to do on February 8. For more information about this
protest, contact the Voters Telecommunications Watch
(vtw@vtw.org), or check their free-speech Web page at
http://www.vtw.org/speech/.
For More Information:
American Civil Liberties Union, 212/944-9800x414 (or its new
Web page, http://www.aclu.org -- or America Online, keyword
'ACLU')
Center for Democracy and Technology, http://www.cdt.org
Electronic Frontier Foundation, http://www.eff.org
Voters Telecommunications Watch, http://www. vtw.org/, or
vtw@vtw.org
***** AIDS TREATMENT NEWS
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AIDS TREATMENT NEWS reports on experimental and
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Treatment News does not recommend particular
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ISSN # 1052-4207
Copyright 1996 by John S. James. Permission granted for
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